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news.Eli Lilly and Company has halted development of a potential diabetes treatment that raised concerns of liver problems.
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Earlier this year, the company said it would delay its regulatory submission for basal insulin peglispro (BIL), the potential once-daily type 1 and type 2 diabetes treatment.
The delay followed changes in liver fat observed with BIL treatment compared with insulin glargine treatment in the Phase 3 Imagine trials.
The company treated over 6,000 patients with type 1 and type 2 diabetes for about 18 months in the trials, with around 3,900 patients treated with BIL.
Eli Lilly did not observe drug-induced liver impairment or Hy’s Law cases. However, the company engaged with regulators and other external experts in the last several months, seeking further clarity on the liver fat data in order to assess potential development plans for BIL that may provide.
The company said that the decision to stop BIL development resulted from those negotiations, and not from any new safety signals. Eli Lilly noted that its focus will now be on research and development efforts on other potential treatments.
Lilly Diabetes president Enrique Conterno said: "While we are encouraged by the efficacy data we observed for BIL, we know that moving forward would have required a significant amount of time and investment with no assurance that we would find conclusive answers.
"We are disappointed in the outcome for BIL, but we have an unprecedented opportunity to build upon the industry’s broadest diabetes portfolio, which includes six new treatments approved since the middle of 2014."